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Core-Based Movement and Nutritional Counselling for Stress and Metabolic Outcomes in Overweight Women With Functional Constipation

2026年8月6日 更新者：Doaa Mohammed Mahmoud Allam、Cairo University

Effects of Core-Based Movement and Nutritional Counselling on Stress, Cortisol, and Lipid Profiles in Overweight Women With Functional Constipation

This study will investigate the effect of core-based movement and nutritional counselling on stress, serum cortisol, and lipid profile in overweight women with functional constipation.

Sixty overweight women with functional constipation will be randomly assigned into two equal groups. The study group will include 30 participants who will receive a core-based movement exercise program for 8 weeks, two sessions per week, in addition to guideline-based nutritional counselling. The control group will include 30 participants who will receive guideline-based nutritional counselling only for 8 weeks.

The outcomes will include perceived stress, serum cortisol level, lipid profile, stool form, sleep quality, and quality of life.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

The practical part of the study will be conducted over 8 weeks, with two sessions per week. Measurements will be taken at baseline before the start of the treatment program and after completion of the 8-week intervention.

A- Evaluative procedures will include

  1. Laboratory investigations for serum cortisol and lipid profile. Blood samples will be collected after an overnight fasting period of 8-12 hours, and 5 mL of venous blood will be drawn from each participant.
  2. Stool form and consistency will be assessed using the Bristol Stool Form Scale, and participants will be instructed to record their bowel movements and stool consistency.
  3. Perceived stress will be assessed using the Perceived Stress Scale.
  4. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index.
  5. Health-related quality of life will be assessed using the 12-Item Short Form Health Survey.

B- Treatment procedures All participants in both groups will receive nutritional counselling for overweight management and functional constipation. The nutritional counselling will be based on guidance provided by the National Institute for Health and Care Excellence (NICE) and the British Dietetic Association (BDA).

  1. Participants in Group A, the study group, will participate in an 8-week core stability-based movement program, two sessions per week, for a total of 16 sessions. They will also receive guideline-based nutritional counselling. Each exercise session will include 5 minutes of warm-up exercises before the core stability-based movement program and 5 minutes of cool-down stretching exercises after the session to ensure participant safety.
  2. Participants in Group B, the control group, will receive guideline-based nutritional counselling only for 8 weeks. The counselling will be based on guidance provided by NICE for overweight management and BDA for dietary management of functional constipation.

C- Statistical analysis : Statistical analysis will be performed using the Statistical Package for the Social Sciences (SPSS), version 25 for Windows. Descriptive statistics will be used to describe the data. Mixed-model ANOVA will be used to determine within-group changes and between-group differences. The level of significance for all statistical tests will be set at p < 0.05.

研究类型

介入性

注册 (估计的)

60

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

  • 姓名：Alaa M ElMoatasem, Assistant professor
  • 电话号码：+2 0 10 06625054
  • 邮箱：doaaallam48@gmail.com

学习地点

  • 埃及
    • Kafr el-Sheikh Governorate
      • Kafr ash Shaykh、Kafr el-Sheikh Governorate、埃及、33511
        • Faculty of Physical Therapy, Kafrelsheikh University
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

Inclusion Criteria:

  • Female participants diagnosed with functional constipation according to Rome IV diagnostic criteria.
  • Age between 18 and 45 years.
  • Body mass index between 25 and 29.9 kg/m².
  • Ability to participate safely in the core-based movement exercise program.
  • Willingness to follow the nutritional counselling program and study procedures.

Exclusion Criteria:

  • Participants will be excluded if they have any organic gastrointestinal disorder or any disease that may affect gastrointestinal transit or colonic function.
  • Participants with inflammatory bowel disease, concurrent infectious enteritis, malignant tumors, or a history of gastrointestinal surgery, including resection of the stomach, small intestine, or large intestine, will be excluded.
  • Participants receiving steroids, antibiotics, immunosuppressive medications, or routinely using laxatives will be excluded.
  • Participants with hyperthyroidism, hypothyroidism, or other endocrine or metabolic disorders that may affect gastrointestinal function will be excluded.
  • Participants with serious cardiovascular, respiratory, renal, hepatic, hematological, neurological, or psychiatric disorders will be excluded.
  • Participants with a history or current evidence of alcohol abuse within the previous year will be excluded.
  • Participants currently engaged in an intense workout regimen will be excluded.
  • Participants with a musculoskeletal disability that may interfere with exercise applicability, such as cervical or lumbar radiculopathy, will be excluded.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
有源比较器：Nutritional Counselling Only
Each participant in this group will receive NICE- and BDA guideline-based nutritional counselling only for overweight management and functional constipation for 8 weeks.
行为的：Guideline-Based Nutritional Counselling
Participants will receive guideline-based nutritional counselling for overweight management and functional constipation. The counselling will be based on guidance provided by the National Institute for Health and Care Excellence (NICE) for overweight management and the British Dietetic Association (BDA) for dietary management of chronic constipation. Counselling will include individualized healthy eating advice, regular meal timing, avoidance of very large or very small meals, adequate hydration, gradual increase of dietary fiber according to tolerance, and encouragement of fiber-rich foods such as vegetables, fruits, whole grains. Participants will also be advised to limit fried foods, processed foods, high-fat foods, excess caffeine, fizzy drinks, refined carbohydrates, and added sugars.
实验性的：Core-Based Movement and Nutritional Counselling
Participants in this group will receive an 8-week core-based movement exercise program, two sessions per week, in addition to NICE- and BDA guideline-based nutritional counselling for overweight management and functional constipation.
行为的：Guideline-Based Nutritional Counselling
Participants will receive guideline-based nutritional counselling for overweight management and functional constipation. The counselling will be based on guidance provided by the National Institute for Health and Care Excellence (NICE) for overweight management and the British Dietetic Association (BDA) for dietary management of chronic constipation. Counselling will include individualized healthy eating advice, regular meal timing, avoidance of very large or very small meals, adequate hydration, gradual increase of dietary fiber according to tolerance, and encouragement of fiber-rich foods such as vegetables, fruits, whole grains. Participants will also be advised to limit fried foods, processed foods, high-fat foods, excess caffeine, fizzy drinks, refined carbohydrates, and added sugars.
行为的：Core-Based Movement Exercise Program

A core-based movement exercise program will include Swan, one leg up-down, leg circles, single-leg stretch, Saw, side kicks, The Hundred, pelvic lift on the ball, sit-ups with the ball, and stretching on the ball. During the first month, sessions 1-8, participants will perform 1 set of 8 repetitions. During the second month, sessions 9-16, participants will perform 2 sets of 10 repetitions.

Guideline-based nutritional counselling for overweight management and functional constipation. The counselling will be based on guidance provided by the National Institute for Health and Care Excellence (NICE) for overweight management and the British Dietetic Association (BDA) for dietary management of chronic constipation. Counselling will include individualized

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in Serum Cortisol Level
大体时间：Baseline and Week 8
Serum cortisol level will be assessed through laboratory investigation. Blood samples will be collected after an 8-12-hour overnight fast.
Baseline and Week 8

次要结果测量

结果测量
措施说明
大体时间
Change in Sleep Quality
大体时间：Baseline and week 8
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index. The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality and a worse outcome.
Baseline and week 8
Change in Health-Related Quality of Life
大体时间：Baseline and week 8
Health-related quality of life will be assessed using the 12-Item Short Form Health Survey. The Physical Component Summary and Mental Component Summary scores are norm-based, with a reference population mean of 50 and a standard deviation of 10. Higher scores indicate better health-related quality of life.
Baseline and week 8
Change in Lipid Profile Parameters
大体时间：baseline and week 8
Description: Lipid profile parameters will be assessed through laboratory investigation, including total cholesterol, triglycerides, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol
baseline and week 8
Change in Perceived Stress Score
大体时间：Time Frame: Baseline and week 8
Perceived stress will be assessed using the Perceived Stress Scale-10. The total score ranges from 0 to 40, with higher scores indicating higher perceived stress and a worse outcome.
Time Frame: Baseline and week 8
Change in stool form , consistency, and frequency
大体时间：Baseline and week 8

Stool form and consistency will be assessed using the Bristol Stool Form Scale. The scale ranges from Type 1 to Type 7, where Types 1-2 indicate separate hard lumps/constipation, Types 3-4 generally indicate normal stool form, and Types 6-7 indicate watery stool/diarrhea.

Weekly stool frequency will be assessed through a daily diary.
Baseline and week 8

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Cairo University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月25日

初级完成 (估计的)

2027年3月30日

研究完成 (估计的)

2027年3月30日

研究注册日期

首次提交

2026年7月5日

首先提交符合 QC 标准的

2026年7月5日

首次发布 (实际的)

2026年7月10日

研究记录更新

最后更新发布 (实际的)

2026年8月10日

上次提交的符合 QC 标准的更新

2026年8月6日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • FPTBSUREC/0513/14526

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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